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Not yet recruiting NCT07704294

Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool

— Observational Optic Neuritis Multiple Sclerosis Neuromyelitis Optica Spectrum Disorder Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Intervention: Observational Cohort.
Who it may be relevant to
Registry conditions: Optic Neuritis, Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool (MS Predictor)

Overview

The goal of this observational study is to determine whether genetic information, together with clinical information, can be used to improve prediction of future multiple sclerosis (MS) diagnosis after a first-time episode of optic neuritis. The study will also investigate visual outcomes, quality of life, healthcare use, and the acceptability of using genetic information to predict future health outcomes in people with optic neuritis. The main outcomes that we aim to assess are: 1. Incident diagnosis of MS following a first episode of optic neuritis, including time to MS diagnosis. 2. Visual outcomes following optic neuritis, including visual acuity, visual field, and colour vision. 3. Clinical care received following optic neuritis, including specialist review, investigations/tests 4. Health-related and vision-related quality of life. 5. Health economic impacts and healthcare utilisation after experiencing optic neuritis 6. Knowledge, attitudes, and practices/behaviours about using genetic information to predict future MS disease risk. If consented, participants will: 1. Allow researchers to review information from their medical records relating to their optic neuritis diagnosis, investigations, treatments, and outcomes. 2. Be invited to provide a saliva sample for genetic analysis. 3. Complete questionnaires about their lifestyle/risk factors, quality of life, and views on genetic risk prediction. 4. Allow researchers to track long-term health outcomes using information from their NHS records

Interventions

  • Other No Intervention: Observational Cohort
    Not applicable - No intervention as this is an observation study

Primary outcome measures

  • Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis [Time frame: Extracted from retrospective record at baseline, and reviewed before study end to capture any new events occurring during the 12 month study period.]
Secondary outcome measures (12)
  • Visual Acuity (LogMAR) [Time frame: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).]
  • Visual Field Mean Deviation (dB) [Time frame: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).]
  • Colour Vision (Number of Ishihara Plates Correctly Identified) [Time frame: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).]
  • Number of Healthcare Consultations Following Optic Neuritis Diagnosis [Time frame: 12 months]
  • Number of Investigations Performed Following Optic Neuritis Diagnosis [Time frame: 12 months]
  • Time to Diagnostic Investigations Following Optic Neuritis Diagnosis (Days) [Time frame: 12 months]
  • Time to Treatment Following Optic Neuritis Diagnosis (Days) [Time frame: 12 months]
  • Number of Treatment Episodes Following Optic Neuritis Diagnosis [Time frame: 12 months]
  • Health-Related Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire [EQ-5D-5L]) [Time frame: Measured at baseline recruitment and repeated 3-12 months later]
  • Vision-Related Quality of Life (National Eye Institute Visual Function Questionnaire-25 [NEI-VFQ-25]) [Time frame: Baseline and repeated 3-12 months later]
  • Optic Neuritis-Related Quality of Life (Semi-Structured Questionnaire) [Time frame: Measured at baseline recruitment and repeated 3-12 months later]
  • Fatigue (Patient-Reported Outcomes Measurement Information System [PROMIS] Fatigue 6a) [Time frame: Baseline recruitment and repeated once 3-12 months later]

Eligibility criteria

Inclusion criteria

  • Aged 16 years and above at time of consent
  • Previous episode of optic neuritis diagnosed at one of the participating sites

Exclusion criteria

  • Patients for whom data relating to the first episode of ON are not available in the medical record at a participating site
  • Children <16 years at the time of recruitment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 3 centers
  • Moorfields Eye Hospital NHS Foundation Trust — London
  • Guy's and St Thomas' NHS Foundation Trust — London
  • King's College Hospital NHS Foundation Trust — London

Publications

  • Panthagani J, O'Donovan C, Aiyegbusi OL, Liu X, Bayliss S, Calvert M, Pesudovs K, Denniston AK, Moore DJ, Braithwaite T. Evaluating patient-reported outcome measures (PROMs) for future clinical trials in adult patients with optic neuritis. Eye (Lond). 2023 Oct;37(15):3097-3107. doi: 10.1038/s41433-023-02478-z. Epub 2023 Mar 17. PMID 36932161
  • Braithwaite T, Wiegerinck N, Petzold A, Denniston A. Vision Loss from Atypical Optic Neuritis: Patient and Physician Perspectives. Ophthalmol Ther. 2020 Jun;9(2):215-220. doi: 10.1007/s40123-020-00247-9. Epub 2020 Mar 21. PMID 32200476
  • Laviers H, Petzold A, Braithwaite T. How far should I manage acute optic neuritis as an ophthalmologist? A United Kingdom perspective. Eye (Lond). 2024 Aug;38(12):2238-2245. doi: 10.1038/s41433-024-03164-4. Epub 2024 Jun 12. PMID 38867071
  • Petzold A, Braithwaite T, van Oosten BW, Balk L, Martinez-Lapiscina EH, Wheeler R, Wiegerinck N, Waters C, Plant GT. Case for a new corticosteroid treatment trial in optic neuritis: review of updated evidence. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):9-14. doi: 10.1136/jnnp-2019-321653. Epub 2019 Nov 18. No abstract available. PMID 31740484
  • Braithwaite T, Subramanian A, Petzold A, Galloway J, Adderley NJ, Mollan SP, Plant GT, Nirantharakumar K, Denniston AK. Trends in Optic Neuritis Incidence and Prevalence in the UK and Association With Systemic and Neurologic Disease. JAMA Neurol. 2020 Dec 1;77(12):1514-1523. doi: 10.1001/jamaneurol.2020.3502. PMID 33017023
  • Loginovic P, Wang F, Li J, Ferrat L, Mirshahi UL, Rao HS, Petzold A, Tyrrell J, Green HD, Weedon MN, Ganna A, Tuomi T, Carey DJ; UKBB Eye & Vision Consortium; FinnGen; Geisinger-Regeneron DiscovEHR Collaboration; Oram RA, Braithwaite T. Applying a genetic risk score model to enhance prediction of future multiple sclerosis diagnosis at first presentation with optic neuritis. Nat Commun. 2024 Feb 28 PMID 38418465

Identifiers

NCT: NCT07704294 · 352834 · 222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗